Background

Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures.

Background and Purpose

The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs.

Background

Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review.

Background

Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial.

Background & purpose

Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains.

Background and purpose:

Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP.

Background

Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT.

Purpose

Clinical trials for common health conditions are constantly being designed and implemented in our institution, often with some urgency to meet funding deadlines. The scope and complexity of these trials has resulted in the need for databased computer management systems typically tailored to each project. Even with current advanced software resources, development, testing and implementation can take months for each new project. This presentation describes a new approach to this problem involving an adaptive table-driven software system using project-specific recruitment and screening data which we have developed using visual basic.

To analyse procedural details - specifically vertebral levels treated and injected polymethylmethacrylate (PMMA) volumes - of the publications by Buchbinder et al. ¹ and Kallmes et al. ² in the context of best available basic science.

Review

Two randomised controlled trials published by the New England Journal of Medicine (NEJM) in 2009 comparing vertebroplasty to sham procedures conclude vertebroplasty to be no more effective than injection of local anaesthetic. This finding contradicts previous publications showing clinical efficacy.

Neither investigation provides a breakdown of vertebral levels treated (original publication and supplementary material). Only one investigation provides information on fill volumes with average of 2.8 ml +/− 1.2 ml SD.

The available basic science indicates a minimum fill volume of 13-16% of the vertebral body volume to be necessary for a relevant biomechanical effect on restoration of vertebral strength, according to which only vertebrae of the upper to mid thoracic spine could reasonably have received a biomechanically effective fill with the declared average volume of 2.8 ml +/− 1.2 ml SD.

The available data of the NEJM publications strongly indicates that the treatment arm includes insufficiently treated patients. The technical information provided by the NEJM publications is insufficient to conclusively prove or disprove the clinical efficacy of vertebroplasty.

Background. Evidence supports that dysfunction of descending inhibition (endogenous analgesic (EA) modulation) contributes towards chronic pain conditions. Research suggests that manual therapy may influence EA modulation; however, this is poorly understood. Trials testing the effect of sustained digital pressure, a commonly used manual therapy technique, using pain pressure threshold (PPT) would give us a better understanding of the influence of manual therapy on EA modulation. A measurement of PPT has been shown to be most effective using fingertip pressure due to the palpatory feedback of symptomatic tissues. Design. A cross-sectional observational study, utilizing a repeated measure approach. Aim. The aim of this research study is to provide preliminary data on the variability of pressure in sustained fingertip pressure in comparison to algometer guided pressure. Methods. Utilizing a pressure algometer, 26 participants were used to test the variability of fingertip pressure in comparison to algometer guided pressure, over 120 seconds. In a randomized order and utilizing two sheets of skin, participants tried to attain, and sustain, a targeted pressure. In the fingertip pressure condition, participants were blinded to the exerted pressure. Conclusion. It was determined that, on average, participants were able to attain the target pressure, but this was highly variable from trial to trial. The test-retest measurement concluded that participants' accuracy was reproducible. Participants were not reproducible in variability when completing the test-retest measurement. There was a relatively higher variability with the lower pressures tested. The order in which the trial was performed, and type of skin did not affect the variability. It was concluded that, whilst some practitioners appear to have a high degree of accuracy with low variability of sustained finger-tip pressure, across a sample population this was not the case bringing into question the mechanism of effect of this common manual therapy technique. Conflict of interest: None. Funding: None

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Aims

The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption.

Background. Osteoarthritis (OA) and chronic low back pain (CLBP > 12 weeks duration) are two of the most common and costly chronic musculoskeletal conditions globally. Healthcare service demands mean that group-based multiple condition interventions are of increasing clinical interest and a priority for research, but no reviews have evaluated the effectiveness of group-based physiotherapy-led self-management interventions (GPSMI) for both conditions concurrently. Rapid review methodologies are an increasingly valid means of expediting knowledge dissemination and are particularly useful for addressing focused research questions. Methods. The electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Register of Controlled Trials were searched from the earliest date possible to August 26. th. 2013. Structured group-based interventions that aimed to promote self-management and that were delivered by health-care professionals (including at least one physiotherapist) involving adults with OA and/or CLBP were eligible for inclusion. The screening and selection of studies, data extraction and risk of bias assessment were conducted independently by two reviewers. Results. 22 studies were found (10 OA, 12 CLBP). The most commonly assessed outcomes were pain, disability, quality of life and physical function. No significant difference was found between the effectiveness of GPSMI and individual physiotherapy or usual general practitioner care for any outcome. Conclusion. GPSMI is as clinically effective as individual physiotherapy, but the best methods of measuring clinical effectiveness warrant further investigation. Further research is also needed to determine the cost-effectiveness of GPSMI and its implications. Conflicts of interest: No conflicts of interest. Sources of funding: This review was conducted as part of Health Research Award HRA_HSR/2012/24 from the Health Research Board of Ireland

Purpose of the study and background. Physical activity and exercise therapy are among the guideline recommendations for the rehabilitation of people with chronic low back pain (CLBP ≥ 3 months); however, patient adherence is often poor. CONNECT is a theory-based communication skills training programme designed to enhance physiotherapists' support of their CLBP patients' psychological needs in order to increase adherence to their home-based rehabilitation programme. Methods and results. The CONNECT trial [Current Controlled Trials ISRCTN63723433] included six Dublin-area public clinics and their physiotherapists (n = 24) who received eight hours of communication skills training from a psychologist [experimental group] and physiotherapists (n = 26) from six equivalent clinics who formed a treatment as usual pragmatic control condition. New patients (n = 255, 54% female) diagnosed with CLBP and receiving physiotherapy at one of these clinics completed ratings of home-based adherence at 1, 4, 12, and 24 weeks after their initial treatment session; 24 weeks was the primary endpoint. Due to the nature of the intervention, physiotherapists were aware of treatment allocation; patients and assessors were blinded. Intention to treat analysis using a linear mixed model approach indicated that patients in the experimental group rated their home-based adherence significantly higher than patients in the control condition across time-points (P = .01), but the difference was not significant at the 24-week follow-up (P > .05). Conclusions. The CONNECT intervention had a positive effect on patients' self-rated adherence to home-based rehabilitation for CLBP, but the impact was not maintained over 24 weeks. Further analysis from the CONNECT trial will investigate its effects on pain and function, as well as hypothesised mediators of change

To identify the validity of the Straight leg raise and crossed straight leg raise in the diagnosis of Lumbar disc prolapse. Systematic review of the literature. The Medline database was used (1966-09) using the search terms Lumbar disc prolapse /disc herniation/straight leg raise /crossed straight leg raise. 80 papers were identified from the search after duplicates had been removed. Of these, 6 abstracts were read and the full papers of 5 reviewed. Four papers scored highly on the STARD criteria and were used in the final review. Two systematic reviews (Vroomen et al, 1999; Deville et al, 2000) and two diagnostic studies (Majessi et al,2000; Vroomen et al, 2002). The review by Vroomen in 1999 identified 37 papers. Trials were included that used CT myelography, MRI or surgical findings as the gold standard. Deville identified 15 studies with the gold standard being findings at surgery. The diagnostic trial by Majessi et al (2008) and Vroomen et al (2002) both used MRI as the gold standard. The Diagnostic odds ratio for SLR ranged from 2.3-8.8 and for CSLR from 4.4 to 11.2. The most valid clinical test in the diagnosis of Lumbar disc prolapse is. the crossed straight leg raise. The straight leg raise has not been shown to have high validity

Purpose of study and background. This systematic review sought to determine the efficacy of such targeted treatment in adults with non-specific low back pain (NSLBP). Many clinicians and researchers believe that tailoring treatment to subgroups of NSLBP positively impacts on patient outcomes. Method and results. MEDLINE, EMBASE, Current Contents, AMED, the Cochrane Central Register of Controlled Trials, reference list searching and citation tracking. Inclusion criteria were randomised controlled trials of targeted manual therapy and/or exercise for NSLPB that used trial designs capable of providing robust information on targeted treatment (treatment effect modification) for the outcomes of activity limitation and pain. Included trials needed to be hypothesis-testing studies published in English, Danish or Norwegian. Method quality was assessed using the Cochrane Back Review Group criteria. Four high-quality trials of targeted manual therapy and/or exercise for NSLBP met the inclusion criteria. One study showed statistically significant effects for short-term outcomes using McKenzie directional preference-based exercise. Other included studies showed effects that might be clinically important in size but were not statistically significant with their samples sizes, as research into subgroups requires much larger sample sizes than traditional two-group trials. Conclusions. The clinical implications of these results are that they provide very cautious evidence supporting the notion that treatment targeted to subgroups of patients with NSLBP may improve patient outcomes. The results were too patchy, inconsistent, and investigated in samples too small for clinical recommendations to be based on these findings. The research implications are that adequately powered controlled trials of treatment effect modification are uncommon

Department of Epidemiology, ASL RM/E, Rome, Italy. School of Health and Social Care, University of Teesside, Middlesbrough, UK. Faculty of Health, Staffordshire University, Stoke on Trent, UK. Orthopaedic and Trauma Department, “Tzanio” General Hospital of Piraeus, Greece. University of Medical Sciences, Poznan, Poland. Department of Orthopaedic Surgery, Saitama Medical University, Kawagoe, Japan. Thriasio General Hospital, Athens, Greece. To evaluate the efficacy of bracing in adolescent patients with AIS. Cochrane systematic review. The following databases were searched with no language limitations: the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINHAL and reference lists of articles. Extensive hand searching of grey literature was also conducted. RCT's and prospective cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces were included. Two review authors independently assessed trial quality and extracted data. Two studies were included. There was very low quality evidence from one prospective cohort study including 286 girls. 1. indicating that braces curbed curve progression, at the end of growth, (success rate 74%), better than observation, (34%) and electrical stimulation (33%). Another low quality evidence from one RCT with 43 girls indicated that a rigid brace is more successful than an elastic one (SpineCor) at limiting curve progression when measured in Cobb degrees. 2. No significant differences between the two groups in the subjective perception of daily difficulties associated with brace wearing were found. There is very low quality evidence in favour of using braces, making generalization very difficult. The results from future studies may differ from these results. In the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short and long-term patient-centred outcomes as well as measures such as Cobb angles. RCTs and prospective cohort studies should follow both the SRS and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) criteria for bracing studies

Aims

The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease.

Aims

The aim of this study was to determine whether the sequential application of povidone iodine-alcohol (PVI) followed by chlorhexidine gluconate-alcohol (CHG) would reduce surgical wound contamination to a greater extent than PVI applied twice in patients undergoing spinal surgery.

Objectives

We performed a systematic review of the literature to determine the safety and efficacy of bone morphogenetic protein (BMP) compared with bone graft when used specifically for revision spinal fusion surgery secondary to pseudarthrosis.